The percentage of the world population suffering from morbid obesity is steadily increasing. Severely obese persons are susceptible to increased risk of heart disease, stroke, diabetes, pulmonary disease, and accidents. Because of the effect of morbid obesity to the life of the patient, methods of treating morbid obesity are being researched.
Numerous non-operative therapies for morbid obesity have been tried with virtually no permanent success. Dietary counseling, behavior modification, wiring a patient's jaws shut, and pharmacologic methods have all been tried, and though temporarily effective, failed to correct the condition. Further, introducing an object in the stomach, such as an esophago-gastric balloon, to fill the stomach have also been used to treat the condition; however, such approaches tend to cause irritation to the stomach and are not effective long-term.
Surgical treatments of morbid obesity have been increasingly used with greater success. These approaches may be generalized as those that reduce the effective size of the stomach, limiting the amount of food intake, and those that create malabsorption of the food that it is eaten. For instance, some patients benefit from adjustable gastric bands (AGB) that are advantageously laparoscopically placed about the stomach to form a stoma of a desired size that allows food to fill an upper portion of the stomach, causing a feeling of satiety. To allow adjustment of the size of the stoma after implantation, a fluid conduit communicates between an inwardly presented fluid bladder of the AGB to a fluid injection port subcutaneously placed in front of the patient's sternum. A syringe needle may then inject or withdraw fluid as desired to adjust the AGB.
Although an effective approach to obesity for some, other patients may find the lifestyle changes undesirable, necessitated by the restricted amount of food intake. In addition, the medical condition of the patient may suggest the need for a more permanent solution. To that end, surgical approaches have been used to alter the portions of the stomach and/or small intestine available for digesting food. Current methods of performing a laparoscopic anastomoses for a gastric bypass include stapling, suturing, and placing biofragmentable rings, each having significant challenges. For instance, suturing is time consuming, as well as being technique and dexterity dependent. Stapling requires placement of an anvil, which is a large device that cannot be introduced through a trocar port. Having to introduce the port through a laparotomy presents an increased incidence of wound site infection associated with intralumenal content being dragged to the laparotomy entry site.
As an example of the latter approach, in U.S. Pat. No. 6,543,456 a method for gastric bypass surgery includes the insertion of proximal and distal anastomosis members (e.g., anvils) transorally with grasping forceps. The stomach and the small intestine are transected endoscopically by a surgical severing and stapling instrument to create a gastric pouch, a drainage loop, and a Roux limb. An endoscopically inserted circular stapler attaches to the distal anastomosis member to join the drainage loop to a distal portion of the intestine, and the circular stapler attaches to the proximal anastomosis member to join the Roux limb to the gastric pouch. Thereafter, the anastomosis members are removed to create an orifice between joined portions of the stomach and intestine. This method reduces the number of laparoscopic ports, avoids a laparoscopic insertion of an anastomosis instrument (e.g., circular stapler) into an enlarged surgical port, and eliminates the need for an enterotomy and an enterotomy closure.
While methods such as that described are a marked improvement over generally known gastric bypass and similar surgical treatments for morbid obesity, it would be desirable to achieve a gastric bypass with yet fewer procedural steps and with fewer laparoscopic insertions. Such an approach is described in U.S. patent application Publ. No. US 2003/0032967 to Park et al., wherein gastrointestinal or enteric (including biliary) anastomosis is achieved by insertion of a sheath that perforates the walls of two tissue passages, such as the stomach and small intestine. A three-dimensional woven tube of wire of having a thermal shape memory effect (SME) is presented by a cannula of the sheath on both sides of the openings. Use of SME material in a cuff-like arterial bypass has been previously used, as described in U.S. Pat. Nos. 5,676,670, 5,797,920 and 6,007,544. Deployment of the woven tube causes the outer loops or ends of the tube to fold or loop back to hold the luminal interface of the anastomosis site in apposition. Thereby, the need for a mechanical compression component in a delivery system is reduced or avoided, reducing the size and complexity of the delivery device.
While this generally known ring device is a significant advancement in the treatment of morbid obesity, it is believed that further improvements would be desirable for clinical effectiveness. In particular, the known ring device is a woven tube, or stent, that is purported to be a self-actuating anastomotic ring. Thus, an applier described for inserting the known ring device merely positions the ring device at the anastomotic site and deploys the ring device by pushing it off of a cannula, relying upon SME attributes of the ring device to cause actuation. Unfortunately, the generally known ring device sometimes will not actuate or transform from its stressed cylindrical state to its relaxed clamping state, perhaps due to irregularities in undulations of its woven designs create friction. One particular difficulty of known SME anastomotic rings are that they are designed to move from a generally cylindrical shape to a hollow rivet shape (“ring shape”) by having wires that form the device move across one another. In particular, wires must move within a nodal point (i.e., an indentation or valley) created by the wire bend and must climb back out of the indentation. In some instances, the device fails to fully actuate on its own due to these sources of friction.
While improvements to the ring device are also desirable, what would mitigate the shortcomings of the generally known ring device is a surgical tool, or applier, that affirmatively and rapidly forms the attachment at an anastomotic surgical site, without having to wait for SME actuating to slowly, if at all, effect attachment. However, such an applier would advantageously allow a single lumen access, unlike the previously known anastomosis procedures that required insertion of anvils and circular staplers.
Moreover, it is believed that having to rely upon an SME actuation sufficiently strong to move from the stressed, unactuated position to the relaxes, actuated position limits the range of material properties and dimensions that otherwise may be selected. For instance, a thinner gauge wire strand may advantageously provide sufficient holding strength until the anastomosis attachment heals, yet releases easily later for letting the now unnecessary ring device to pass out of the patient. Yet, this thinner gauge wire strand would be unable to incorporate sufficient SME strength to overcome internal friction and to draw together apposite tissue walls during actuation.
In addition, a current challenge for using a single lumen anastomosis procedure is that it is desired for clinical efficiency and for minimizing patient recovery time that the anastomosis site be approached from one side of the apposite pair of tissue walls of two adjacent tissue passages (e.g., stomach and small intestine). Yet, only one of the tissue walls and a proximal side of a deployed ring device are readily visible from this vantage point, when viewed by an endoscope or similar optical imaging device. Confirming that a successful anastomotic attachment has occurred is highly desirable.
Consequently, there is a general need for an approach to anastomosis that will use existing trocar ports (e.g., 12 mm size) with a minimum of suturing. Moreover, aspects of the method should have application to endoscopic surgery. To that end, a significant need exists for an anastomosis device that reliably and effectively deploys and actuates to eliminate the need for surgical stapling and suturing to form an anastomosis.